首页> 外文期刊>Clinical therapeutics >Comparison of topical tobramycin-dexamethasone with dexamethasone-neomycin-polymyxin and neomycin-polymyxin-gramicidin for control of inflammation after cataract surgery: results of a multicenter, prospective, three-arm, randomized, double-masked, co
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Comparison of topical tobramycin-dexamethasone with dexamethasone-neomycin-polymyxin and neomycin-polymyxin-gramicidin for control of inflammation after cataract surgery: results of a multicenter, prospective, three-arm, randomized, double-masked, co

机译:局部妥布霉素-地塞米松与地塞米松-新霉素-多粘菌素和新霉素-多粘菌素-短杆菌肽在白内障手术后控制炎症的比较:多中心,前瞻性,三臂,随机,双掩蔽,联合治疗的结果

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BACKGROUND: Intraocular inflammation is typically treated with a combination of anti-inflammatory and anti-infective drugs. Tobramycin-dexamethasone (TD) has not been associated with any serious adverse events, indicating good tolerability. OBJECTIVE: The aims of this study were the following: (1) to demonstrate noninferiority of TD compared with dexamethasone-neomycin-polymyxin (DNP) in terms of anti-inflammatory efficacy, (2) to compare the anti-inflammatory efficacy of TD and DNP with that of a "placebo" control (antibiotic without anti-inflammatory agent), and (3) to provide additional safety data on TD. METHODS: This prospective, double-masked, parallel-group study was conducted at 22 ophthalmology clinics across Europe and Brazil. Patients aged > 18 years undergoing cataract surgery were randomly assigned, in a 2:2:1 ratio, to receive tobramycin 3 mg/mL plus dexamethasone 1 mg/mL, dexamethasone 1 mg/mL plus neomycin sulfate 3500 IU/mL plus polymyxin B sulfate 6000 IU/mL, or neomycin sulfate 3500 IU/mL plus polymyxin B sulfate 7500 IU/mL plus gramicidin 20 microg/mL. All treatments were given as 1 drop instilled in the operated eye q.i.d. for 21 days. The primary efficacy end point, intraocular inflammation (determined using the sum of scores on anterior chamber cells and aqueous flare), was assessed at days 3, 8, 14, and 21 after surgery. RESULTS: A total of 271 patients were enrolled (158 women, 113 men; age range 42-90 years) (TD, 104 patients; DNP, 110 patients; and neomycin-polymyxin-gramicidin [NPG], 57 patients). Intraocular inflammation was similar in the TD and DNP groups at all time points. At days 8, 14, and 21, inflammation scores were significantly lower with TD than with NPG (all, P < 0.05). At day 8, the inflammation score was significantly lower with DNP than with NPG (P < 0.05). A greater number of patients receiving NPG experienced treatment-related ocular allergic reactions compared with patients receiving TD (P < 0.05). One patient receiving TD (1.0%) and 5 given NPG (9.0%) were withdrawn due to ocular allergic reactions. None of the patients experienced an increase in intraocular pressure > or =10 mm Hg from baseline. CONCLUSIONS: In this study of patients undergoing cataract surgery combination therapy with TD was noninferior to DNP and was well tolerated.
机译:背景:眼内炎症通常用抗炎药和抗感染药联合治疗。妥布霉素-地塞米松(TD)未与任何严重不良事件相关,表明其良好的耐受性。目的:本研究的目的如下:(1)在抗炎功效方面证明与地塞米松-新霉素-多粘菌素(DNP)相比,TD的非劣效性;(2)比较TD和DNP与“安慰剂”对照(不含抗炎药的抗生素),以及(3)提供有关TD的其他安全性数据。方法:这项前瞻性,双重掩盖,平行组研究在欧洲和巴西的22家眼科诊所进行。年龄大于18岁的白内障手术患者按2:2:1的比例随机分配接受妥布霉素3 mg / mL加上地塞米松1 mg / mL,地塞米松1 mg / mL加上硫酸新霉素3500 IU / mL加上多粘菌素B硫酸盐6000 IU / mL,或硫酸新霉素3500 IU / mL,加上硫酸多粘菌素B 7500 IU / mL,再加上短杆菌肽20微克/ mL。所有治疗均以q.i.d手术眼滴入1滴的方式进行。持续21天。在手术后第3、8、14和21天评估了主要的疗效终点,即眼内炎症(由前房细胞和房室耀斑的得分之和确定)。结果:共纳入271例患者(158例女性,113例男性;年龄在42-90岁之间)(TD,104例; DNP,110例;新霉素-多粘菌素-葡菌素[NPG],57例)。在所有时间点,TD和DNP组的眼内炎症相似。在第8、14和21天,TD的炎症评分显着低于NPG(所有,P <0.05)。在第8天,DNP的炎症评分显着低于NPG(P <0.05)。与接受TD的患者相比,接受NPG的患者经历了与治疗相关的眼部过敏反应(P <0.05)。由于眼部过敏反应,撤回了1例接受TD治疗的患者(1.0%)和5例接受NPG治疗的患者(9.0%)。没有一个患者的眼压比基线升高或≥10 mm Hg。结论:在这项接受白内障手术的患者的研究中,TD联合治疗不逊于DNP并且耐受性良好。

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